Ex Parte DosmannDownload PDFBoard of Patent Appeals and InterferencesMay 25, 201110367690 (B.P.A.I. May. 25, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/367,690 02/19/2003 Andrew J. Dosmann MSE #2651 1935 71331 7590 05/25/2011 NIXON PEABODY LLP 300 S. Riverside Plaza, 16th Floor CHICAGO, IL 60606-6613 EXAMINER HOEKSTRA, JEFFREY GERBEN ART UNIT PAPER NUMBER 3736 MAIL DATE DELIVERY MODE 05/25/2011 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ANDREW J. DOSMANN __________ Appeal 2011-002033 Application 10/367,690 Technology Center 3700 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and LORA M. GREEN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner‟s rejection of claims 1-10, 12-17, and 25-27. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2011-002033 Application 10/367,690 2 STATEMENT OF THE CASE Claims 1 and 10 are representative of the claims on appeal, and read as follows: 1. A lance adapted to harvest a sample for an optical format, the lance comprising: a lance body, said lance body defined by a multisided tube wherein each side is planar and of a material that allows transmission of light sufficient for optically reading said sample within the lance body, said multisided tube including a first end, said first end having a sharp point adapted to pierce skin and harvest said sample. 10. An optical format with an integrated lance, comprising: a housing, said housing having a first side and a second side, openings in said first side and said second side for passage of light through said housing; and a lance defined by at least one flat surface, the lance being adapted to harvest said sample and being mounted in said housing, said lance formed of translucent material sufficient for optically reading the sample, said lance having a sharp end that is adapted to pierce skin and harvest said sample. The following grounds of rejection are before us for review: I. Claims 1, 5, and 25 stand rejected under 35 U.S.C.§ 102(b) as being anticipated by Humphrey. 1 II. Claims 2 and 3 stand rejected under 35 U.S.C.§ 103(a) as being rendered obvious by the combination of Humphrey and Schenk. 2 III. Claim 4 stands rejected under 35 U.S.C. §103(a) as being rendered obvious by the combination of Humphrey, Schenk, and Smart. 3 1 Humphrey, US 5,607,401, issued Mar. 4, 1997 2 Schenk et al., US 5,545,174, issued Aug. 13, 1996. 3 Smart et al., US 5,801,057, issued Sep. 1, 1998. Appeal 2011-002033 Application 10/367,690 3 IV. Claims 6, 7, and 9 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Humphrey and Smart. V. Claim 8 stands rejected under 35 U.S.C. §103(a) as being rendered obvious by the combination of Humphrey and Comley. 4 VI. Claims 10, 12, 15-17, and 26-29 stand rejected under 35 U.S.C. §103(a) as being rendered obvious by the combination of Smart and Humphrey. VII. Claim 13 stands rejected under 35 U.S.C. §103(a) as being rendered obvious by the combination of Smart, Humphrey, and Schenk. VIII. Claim 14 stands rejected under 35 U.S.C.§ 103(a) as being rendered obvious by the combination of Smart, Humphrey, and Comley. We affirm. ISSUE (Rejections I-IV) Has the Examiner established by a preponderance of the evidence that Humphrey anticipates the lance of claim 1? FINDINGS OF FACT FF1 The Specification teaches that the invention is drawn to a lance and optical format to harvest a small blood sample, wherein the sample can be analyzed with conventional transmission spectroscopy (Spec. 1). 4 Comley et al., US 6,652,809 B1, issued Nov. 25, 2003. Appeal 2011-002033 Application 10/367,690 4 FF2 The Specification further teaches that capillary action is used to draw sample into the lance, where it reacts with reagents coated on the walls of the capillary, producing a color change (id.). FF3 According to the Specification: The optical format with integrated lance . . . is used to pierce the skin of a patient with the sharp point . . . . Once a drop of blood appears at the puncture site, the tip or first end . . . of the lance . . . is returned to the drop of blood and capillary action draws a sample into the square channel . . . . Another embodiment would leave the lance below the surface of the skin until capillary action or vacuum assisted capillary action obtains a sample. The sample is allowed to react with the dried chemistry . . . coated onto the capillary walls which produces a color change to the sample. The change in color is proportional to analyte concentration. The sample is then read with transmission spectrometry by passing a monochromatic collimated beam of light through the portion of the lance . . . in the housing . . . by passing the beam through one of the openings . . . in the housing . . . (Id. at 4.) FF4 The anticipation rejection (Rejection I) may be found at pages 4-5 of the Answer. As Appellant does not argue the claims separately, we focus our analysis on claim 1, and claims 5 and 25 stand or fall with that claim. See 37 C.F.R. § 41.37(c)(1)(vii). FF5 Specifically, the Examiner finds that Humphrey teaches a lance body “of a material that allows transmission of light (column 2 lines 43-45, column 4 lines 5-15, column 12 lines 15-30, and column 14 lines 1-6) sufficient for optically reading said sample within the lance body (column 2 lines 43-45)” (Ans. 4). Appeal 2011-002033 Application 10/367,690 5 FF6 The Examiner finds further that “an optical reading and/or analysis may be performed solely by the eyes of a patient or clinical technician reading for example the color-coded results of an electrochemical reaction of bodily fluid with an analytical reagent” (id. at 20). FF7 Specifically, Humphrey is drawn to a flexible, polymeric hypodermic needle or lancet (see Humphrey, col. 2, ll. 27-30), which can be made to be clear or light transmissive to permit the blood or medication within to be viewed (see id. at col. 2, ll. 43-44). FF8 Humphrey teaches that the needles or lancets according to the invention are less costly to manufacture than conventional hypodermic devices, and may be destroyed or rendered harmless by incineration (see id. at col. 2, ll. 50-54). PRINCIPLES OF LAW To anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim. See Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). During prosecution before the Office, claims are to be given their broadest reasonable interpretation consistent with the Specification as it would be interpreted by one of ordinary skill in the art. See In re American Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). “An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative Appeal 2011-002033 Application 10/367,690 6 process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). Moreover, it is during prosecution that applicants have “the opportunity to amend the claims to obtain more precise claim coverage.” American Academy, 367 F.3d at 1364. We also decline to read limitations from the Specification into the claims, a practice that the Court of Appeals for the Federal Circuit, our reviewing court, cautions against. See SuperGuideCorp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.”). ANALYSIS As to Rejection I, Appellant argues that Humphrey does not disclose, teach, or suggest a lance body „of a material that allows transmission of light sufficient for optically reading said sample within the lance body,‟ as recited in claim 1” (App. Br. 8). According to Appellant, while Humphrey teaches that the needle is clear to permit viewing of the blood sample within, that is very different from a material that is useful for optically reading a sample (see id. at 8-9). Appellant asserts that the lance of claim 1 “is of a much more specialized type of material – one that allows transmission of light sufficient for optically reading a sample” (id. at 9). Appellant cites page 4 of the Specification (see FF3) to support their contention that “the present [S]pecification makes clear that a material „sufficient for optically reading Appeal 2011-002033 Application 10/367,690 7 said sample‟ requires substantially more than Humphrey‟s clear material for „permit[ting] the blood or medication within to be viewed‟” (id. at 9-10). Claim 1 is drawn to a product, that is a lance, wherein the lance body is defined by a body “that allows transmission of light sufficient for optically reading said sample within the lance body.” We agree with the Examiner that the polymeric lancet of Humphrey is made of a material that allows for the transmission of light sufficient for optically reading a sample, for example, such as optically reading a color change by visual inspection. Moreover, although the Specification discusses using transmission spectrometry (see FF3), the Specification does not appear to define “optical reading of a sample” as being limited to such. Thus, the claim is not limited to only those materials that would allow for reading the sample by transmission spectrometry. And while the Appellant asserts that the polymeric material of Humphrey would not be suitable for reading by such a method, they have provided no evidence to support that assertion, and arguments of counsel cannot take the place of evidence in the record. See In re Scarbrough, 500 F.2d 560, 566 (CCPA 1974). As to Rejection II, Appellant argues that Schenk does not remedy the deficiencies of Humphrey, and reiterate the arguments made with respect to Rejection I (see App. Br. 12). We thus affirm this rejection for the reasons set forth above with respect to Rejection I. As to Rejection III, Appellant argues that Smart does not remedy the deficiencies of Humphrey and Schenk, and reiterate the arguments made with respect to Rejection I (see id. at 12-13). We thus affirm this rejection for the reasons set forth above with respect to Rejection I. Appeal 2011-002033 Application 10/367,690 8 As to Rejection IV, Appellant argues that Smart does not remedy the deficiencies of Humphrey, and reiterate the arguments made with respect to Rejection I (see id. at 13). We thus affirm this rejection for the reasons set forth above with respect to Rejection I. CONCLUSION OF LAW We conclude that the Examiner has established by a preponderance of the evidence that Humphrey anticipates the lance of claim 1. We thus affirm Rejections I-IV. ISSUES (Rejections V-VIII) Has the Examiner established by a preponderance of the evidence that the combination of Humphrey and Comley renders obvious the lance of claim 8? Has the Examiner established by a preponderance of the evidence that the combination of Smart and Humphrey renders obvious the optical format of claim 10? FINDINGS OF FACT FF9 The Examiner‟s statement of Rejection V may be found at page 11 of the Answer. FF10 Specifically, the Examiner finds that Humphrey teaches the invention of claim 8, except “for expressly disclosing [that] the material is fused silica” (Ans. 11). Appeal 2011-002033 Application 10/367,690 9 FF11 The Examiner notes that Humphrey teaches the use of a material that comprises in part randomly dispersed glass fibers (see id.). FF12 The Examiner also finds that “[i]t is well known in the art of bodily piercing and fluid sampling lancets to substitute teachings of well known materials to improve the efficacy of the lancet to function as an optical- based diagnostic lancet” (id.). FF13 The Examiner cites Comley for teaching “blood-receiving translucent capillary tubes comprising fused silica material in a member (column 3 lines 56-61)” (id.). FF14 Specifically, Comley teaches: Capillaries may be manufactured from a range of translucent materials, e.g. plastics (such as perspex), glasses (such as fused silica) and quartz. It is preferred that the material gives a low background reading in the optical assay method used. Glasses and quartz are especially preferred, particularly fused silica which demonstrates low phosphorescence. (Comley, col. 3, ll. 56-62.) FF15 The Examiner concludes that it would have been obvious to use the fused silica of Comley in the lancet of Humphrey “to achieve the predictable results of providing an optically transparent lance tube” (Ans. 11). FF16 The Examiner‟s statement of Rejection VI may be found at pages 11- 16 of the Answer. As Appellant does not argue the claims separately, we focus our analysis on claim 10, and claims 12, 15-17, and 26-29 stand or fall with that claim. FF17 The Examiner finds that Smart teaches an optical format with an integrated lance that meets the limitations of claim 10, except that Smart Appeal 2011-002033 Application 10/367,690 10 fails to disclose that the tube is defined by at least one flat surface (see Ans. 11-12). FF18 The Examiner finds, however, that “it is well known in the art of bodily piercing and fluid sampling lancets to substitute one cross-sectional shape for an alternate one” (id. at 12). FF19 The Examiner cites Humphrey for teaching “a lancet defined by a multisided tube (the hollow triangular tube as best seen in Figure 51) (column 14 lines 51-54) wherein each side is planar and defined by a flat surface (each side of the hollow triangular tube is planar as best seen in Figure 51) (column 14 lines 51-54)” (id. at 12-13). FF20 We note further that Humphrey teaches: An open trough or "V" shaped puncturing part was selected as ideal. Previous research has shown that "V" shaped needles require less force to puncture the skin than do conventional round needles. Further, a "V" shape would lend itself to unhardened metals, and composite materials, as well as to hardened stainless steel. A "V" shape could also be formed with a novel, plow shaped structure at the tip which would separate and push aside the tissue to reduce coring. (Humphrey, col. 3, ll. 50-61.) FF21 The Examiner concludes that it would have been obvious to combine the lancet tube characteristics of Humphrey comprising a flat surface with the lancet tube characteristics of Smart “to achieve the predictable result[ ] of providing an alternate lance body cross-sectional shape to aid in harvesting a blood sample with a lance body” (Ans. 13). Appeal 2011-002033 Application 10/367,690 11 PRINCIPLES OF LAW The Supreme Court has recently emphasized that “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S. 398. 418 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. Moreover, an “[e]xpress suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). ANALYSIS As to Rejection V, Appellant argues that Comley cannot be combined with Humphrey because Humphrey teaches away from such a combination (see App. Br.13). Specifically, Appellants argue that Humphrey teaches the use of a low cost material (see id. at 10), and thus the ordinary artisan would not consider modifying it with fused silica (see id. at 13). Appellant‟s arguments are not found to be convincing. Humphrey teaches the advantages of having a lance body that is translucent to light, and as taught by Comley, both polymers such as plastic and fused silica are known by the ordinary artisan to be translucent materials (see e.g., FF14). The ordinary artisan would also understand the disadvantages, as well as the benefits of different types of materials, such as fused silica and plastic. See, e.g., In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994) (“[a] known or obvious Appeal 2011-002033 Application 10/367,690 12 composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use”). Thus, we agree with the Examiner that it would have been obvious to another type of translucent material, such as fused silica, in the lancet of Humphrey. As to Rejection VI, Appellant argues first that that the combination of Smart and Humphrey does not result in the claimed optical format, because, as argued in response to the anticipation rejection, Appellants assert that the needle of Humphrey “is not „formed of a translucent material sufficient for optically reading a sample‟” (App. Br. 14). That argument is not found to be convincing for the reasons set forth above with respect to the anticipation rejection. We further note that the Examiner did not rely on Humphrey for teaching the use of a translucent material, but instead found that Smart teaches that the lance is formed in part of a translucent material for optically reading the sample (see Ans. 12), and Appellant has not pointed to any error in that fact finding. Rather, the Examiner relied upon Humphrey for teaching a lancet defined by a multisided tube wherein the sides of the tube are planar (see id., see also FF19). Appellant argues further that the ordinary artisan would not combine Humphrey with Smart, as the device of Smart has a small sampling chamber that has a volume less than one microliter, whereas the device of Humphrey is directed to a device for withdrawing relatively large amounts of blood (see App. Br. 14). Moreover, Appellant asserts that “Humphrey has no relevance to optically testing analytes,” and that because Humphrey teaches the low cost of its device, one would not modify it for optical testing (id. at 15). Appeal 2011-002033 Application 10/367,690 13 Finally, Appellant argues that the modes of operation of Humphrey and Smart are different, as Smart relies on capillary action to drawn in fluid gathered on the surface of the skin, whereas Humphrey uses a force or vacuum to draw in or expel fluid (see id.). As noted above, the Examiner relied upon Humphrey for teaching a lancet having a cross-section wherein the cross-section has at least one flat side. Thus, we agree with the Examiner that it would have been obvious to use any known lance cross section, such as that taught by Humphrey, for the cross-section of the lance of Smart. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art”.) Moreover, Appellant has provided no evidence or sound scientific reasoning as to why the ordinary artisan would not expect that cross-section to function in the device of Smart. As to Rejection VII, Appellant argues that Schenk does not remedy the deficiencies of the combination of Smart and Humphrey (see App. Br. 15-16). As to Rejection VIII, Appellant argues that Comley does not remedy the deficiencies of the combination of Smart and Humphrey (see App. Br. 16). Those arguments are not found to be convincing for the reasons set forth above with respect to the response to the arguments as to Rejection VI. Appeal 2011-002033 Application 10/367,690 14 CONCLUSIONS OF LAW We conclude that the Examiner established by a preponderance of the evidence that the combination of Humphrey and Comley renders obvious the lance of claim 8. We thus affirm Rejection V. We further conclude that the Examiner has established by a preponderance of the evidence that the combination of Smart and Humphrey renders obvious the optical format of claim 10. We thus affirm rejections VI-VIII. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)§ 41.50(b). AFFIRMED alw Copy with citationCopy as parenthetical citation